Label: HYDROCORTISONE 1%- hydrocortisone cream
- NDC Code(s): 69396-050-01, 69396-050-05
- Packager: Trifecta Pharmaceuticals Usa Llc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 2, 2024
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- Official Label (Printer Friendly)
- DRUG FACTS
- Active ingredient
- Purpose
- KEEP OUT OF REACH OF CHILDREN
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Uses
For temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:
● eczema ● seborrheic dermatitis ● psoriasis ● insect bites ● poison ivy, oak, sumac ● soaps
● detergents ● cosmetics ● jewelry ● external feminine genital and anal itching
Other uses of this product should be only under the advice and supervision of a doctor
- Warnings
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When using this product
- Avoid Contact with the eyes
- Do not begin the use of any other hydrocortisone product unless you have consulted a doctor
- For external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use and consult a doctor.
- do not put this product into the rectum by using fingers or any medicated device or applicator.
- Stop using this product and ask a doctor if
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Directions
Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.
Children under 2 years of age: do not use, consult a doctor.
For External and anal itching:
Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
Children: under 12 years of age with external anal itching: consult a doctor.
- Inactive ingredients
- Other information
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE 1%
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength ETHYLPARABEN (UNII: 14255EXE39) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETYL ALCOHOL (UNII: 936JST6JCN) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69396-050-01 1 in 1 BOX 12/12/2019 1 28.4 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69396-050-05 1 in 1 BOX 09/01/2022 2 14.2 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 12/12/2019 Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)
